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Clinical trialNCT03209024UnknownInterventional

Smartphone App Assisted Home Blood Pressure Monitoring Amongst Hypertensive Patients in Singapore

SponsorDuke-NUS Graduate Medical SchoolEnrollment80Hypertension
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: Hypertension is the leading attributable risk factor for cardiovascular disease and death globally. In diagnosing and monitoring hypertensive patient population, home blood pressure monitoring (HBPM) has been shown to be superior to the office-based blood pressure (BP) measurement as a predictor of cardiovascular disease and total mortality. However, the conventional method of HBPM utilizing handwritten BP logbooks has known shortcomings, mainly attributable to inaccuracy and underreporting of data, as well as the failure to bring the logbooks to the regular outpatient appointments. In recent years, the availability of home BP devices with Bluetooth® technology on the market, the increasingly widespread use of smartphones, and the development of mobile applications (apps) that complement Bluetooth® enabled BP monitors have expanded the potential for an accurate log of BP data to be accessible to clinicians. Our study's primary aim is to compare the level of HBPM recording fidelity using smartphone app versus using a handwritten logbook among the multi-ethnic hypertensive patient population seen in a district polyclinic located in Pasir Ris, Singapore. Patient acceptability of the two recording modalities and the association between the home blood pressure recording fidelity and the patients' socio-demographic background, self-care profile, clinical factors, and level of exposure to technology is also assessed as exploratory aims. Our main hypothesis is that the level of fidelity in HBPM recording, defined as the proportion of scheduled number of home blood pressure readings that is successfully recorded, regimen compliant, and made available at the final follow up visit, would be higher for patients who use a smartphone app versus those who maintain a handwritten logbook. Methods/design: Open, randomized controlled trial of 80 patients seen at Pasir Ris Polyclinic randomized to either intervention or control arm and assessed after a 3-week follow up period Intervention arm: Participants randomized to intervention arm follow a 3-week HBPM regimen and wirelessly record the BP readings onto a smartphone app using Bluetooth® technology. Control arm: Participants randomized to control arm follow a 3-week HBPM regimen (identical to intervention arm) and manually record the BP readings onto a handwritten logbook. Participants: A convenience sample of 80 patients visiting the study polyclinic was obtained during the recruitment period (15 Mar 2017 - 15 June 2017). Outcomes: A trained outcomes assessor will assess each participant's home BP record brought to the final follow up visit at 3 weeks post-randomization. The primary outcome will be HBPM recording fidelity, defined as the proportion of scheduled number of home blood pressure readings that is successfully recorded, regimen compliant, and made available at the final follow up visit. The participants' level of discomfort during the study, their willingness to incorporate into their healthcare management the modality of HBPM to which they were assigned, and their overall impression on their study participation will be assessed by a participant acceptability questionnaire.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Singapore
  • Singhealth Polyclinics - Pasir Ris

    Singapore, Singapore

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Mar 2017
Primary completion
31 Jul 2017
Completion
31 Jul 2017
Last update posted
6 Jul 2017
Registered enrollment
80
Registry id
NCT03209024

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.